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Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) (SCORE2)

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ClinicalTrials.gov Identifier: NCT01969708
Recruitment Status : Active, not recruiting
First Posted : October 25, 2013
Results First Posted : August 21, 2018
Last Update Posted : May 8, 2019
Sponsor:
Collaborators:
National Eye Institute (NEI)
Milton S. Hershey Medical Center
University of Wisconsin, Madison
Information provided by (Responsible Party):
The Emmes Company, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Central Retinal Vein Occlusion
Interventions Drug: aflibercept
Drug: bevacizumab
Enrollment 362
Recruitment Details The SCORE2 randomized noninferiority clinical trial was conducted at 66 private practice or academic centers in the United States, and included 362 patients with macular edema due to central retinal or hemiretinal vein occlusion who were randomized 1:1 to receive aflibercept or bevacizumab.
Pre-assignment Details Participants were assigned to a treatment arm at enrollment.
Arm/Group Title Aflibercept Bevacizumab
Hide Arm/Group Description

2.0 mg aflibercept every 4 weeks

aflibercept

1.25 mg bevacizumab every 4 weeks

bevacizumab

Period Title: Overall Study
Started 180 182
Completed 175 173
Not Completed 5 9
Arm/Group Title Aflibercept Bevacizumab Total
Hide Arm/Group Description

2.0 mg aflibercept every 4 weeks

aflibercept

1.25 mg bevacizumab every 4 weeks

bevacizumab

Total of all reporting groups
Overall Number of Baseline Participants 180 182 362
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
67
  37.2%
67
  36.8%
134
  37.0%
>=65 years
113
  62.8%
115
  63.2%
228
  63.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
Female
82
  45.6%
75
  41.2%
157
  43.4%
Male
98
  54.4%
107
  58.8%
205
  56.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
Hispanic or Latino
16
   8.9%
22
  12.1%
38
  10.5%
Not Hispanic or Latino
164
  91.1%
160
  87.9%
324
  89.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
American Indian or Alaska Native
8
   4.4%
2
   1.1%
10
   2.8%
Asian
4
   2.2%
2
   1.1%
6
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
28
  15.6%
26
  14.3%
54
  14.9%
White
132
  73.3%
146
  80.2%
278
  76.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
   4.4%
6
   3.3%
14
   3.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 180 participants 182 participants 362 participants
180 182 362
Visual Acuity Letter Score (VALS) of Study Eye   [1] 
Mean (Standard Deviation)
Unit of measure:  Letters read
Number Analyzed 180 participants 182 participants 362 participants
50.3  (15.2) 50.4  (15.3) 50.3  (15.2)
[1]
Measure Description: The participant is refracted for best corrected vision, and then reads single letters on an electronic visual acuity tester at a 3 meter distance according to a specific algorithm. A letter score is provided that ranges from 0 (unable to ready any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent.
Time between diagnosis of macular edema and randomization  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 180 participants 182 participants 362 participants
8  (17) 5  (10) 7  (14)
Spectral Domain-Optical Coherence Tomography (SD-OCT) central subfield thickness  
Mean (Standard Deviation)
Unit of measure:  Um
Number Analyzed 180 participants 182 participants 362 participants
652.4  (214.6) 678.2  (233.3) 665.5  (224.4)
Prior anti-vascular endothelial growth factor (VEGF) treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
65
  36.1%
56
  30.8%
121
  33.4%
Prior intravitreal steroid use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
16
   8.9%
12
   6.6%
28
   7.7%
Hemiretinal vein occlusion  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
26
  14.4%
31
  17.0%
57
  15.7%
Cataract extraction  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
43
  23.9%
55
  30.2%
98
  27.1%
History of cataract  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
108
  60.0%
95
  52.2%
203
  56.1%
Diabetes mellitus type 1  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
1
   0.6%
0
   0.0%
1
   0.3%
Diabetes mellitus type 2  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
54
  30.0%
59
  32.4%
113
  31.2%
Hypertensive  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
140
  77.8%
138
  75.8%
278
  76.8%
Coronary artery disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 182 participants 362 participants
26
  14.4%
30
  16.5%
56
  15.5%
National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25 overall score   [1] 
Mean (Standard Deviation)
Unit of measure:  Total score
Number Analyzed 180 participants 182 participants 362 participants
77  (15) 77  (17) 77  (16)
[1]
Measure Description: For the National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25, respondents answer a series of multiple-choice questions about their vision and how it affects daily life. The overall scores range from 0 to 100, with higher scores representing better functioning.
1.Primary Outcome
Title Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6
Hide Description The primary analysis is based on observed data at 6 months. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters on an electronic visual acuity tester at a 3 meter distance according to a specific algorithm. A letter score is provided that ranges from 0 (unable to ready any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent.
Time Frame Month 0 to 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with visual acuity letter score recorded at Month 6
Arm/Group Title Aflibercept Bevacizumab
Hide Arm/Group Description:

2.0 mg aflibercept every 4 weeks

aflibercept

1.25 mg bevacizumab every 4 weeks

bevacizumab

Overall Number of Participants Analyzed 175 173
Mean (95% Confidence Interval)
Unit of Measure: letters read
18.9
(16.62 to 21.15)
18.6
(16.16 to 21.09)
2.Secondary Outcome
Title Number of Study Eyes With Gain of ≥15 Letters in Visual Acuity Letter Score at Month 6
Hide Description The measure is the number of study eyes that gained at least 15 letters in their visual acuity letter score at month 6
Time Frame Month 0 to 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with visual acuity letter score recorded at Month 6
Arm/Group Title Aflibercept Bevacizumab
Hide Arm/Group Description:

2.0 mg aflibercept every 4 weeks

aflibercept

1.25 mg bevacizumab every 4 weeks

bevacizumab

Overall Number of Participants Analyzed 175 173
Measure Type: Number
Unit of Measure: study eyes
114 106
3.Secondary Outcome
Title Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6
Hide Description The measure is the number of study eyes with a visual acuity letter score of 70 (Snellen equivalent of 20/40) or better at month 6
Time Frame Month 0 to 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with visual acuity letter score recorded at Month 6
Arm/Group Title Aflibercept Bevacizumab
Hide Arm/Group Description:

2.0 mg aflibercept every 4 weeks

aflibercept

1.25 mg bevacizumab every 4 weeks

bevacizumab

Overall Number of Participants Analyzed 175 173
Measure Type: Number
Unit of Measure: study eyes
101 99
4.Secondary Outcome
Title Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness
Hide Description The measure is the mean central subfield thickness at month 6 measured by spectral-domain optical coherence tomography
Time Frame Month 0 to 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with central subfield thickness recorded at baseline and Month 6
Arm/Group Title Aflibercept Bevacizumab
Hide Arm/Group Description:

2.0 mg aflibercept every 4 weeks

aflibercept

1.25 mg bevacizumab every 4 weeks

bevacizumab

Overall Number of Participants Analyzed 164 171
Mean (95% Confidence Interval)
Unit of Measure: um
231.3
(220.8 to 241.8)
287.9
(269.4 to 306.4)
5.Secondary Outcome
Title Mean Change From Baseline in Spectral Domain Optical Coherence Tomography Central Subfield Thickness at Month 6
Hide Description The measure is calculated by subtracting the baseline central subfield thickness from the month 6 central subfield thickness
Time Frame Month 0 to 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with central subfield thickness recorded at baseline and Month 6
Arm/Group Title Aflibercept Bevacizumab
Hide Arm/Group Description:

2.0 mg aflibercept every 4 weeks

aflibercept

1.25 mg bevacizumab every 4 weeks

bevacizumab

Overall Number of Participants Analyzed 164 171
Mean (95% Confidence Interval)
Unit of Measure: um
-425
(-461 to -389)
-387
(-426 to -348)
6.Secondary Outcome
Title Number of Study Eyes With Central Subfield Thickness <300 μm, no Subretinal Fluid, no Intraretinal Fluid, and no Cystoid Spaces
Hide Description The measure is the number of study eyes with central subfield thickness <300 μm, no subretinal fluid, no intraretinal fluid, and no cystoid spaces at month 6
Time Frame Month 0 to 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with central subfield thickness recorded at Month 6
Arm/Group Title Aflibercept Bevacizumab
Hide Arm/Group Description:

2.0 mg aflibercept every 4 weeks

aflibercept

1.25 mg bevacizumab every 4 weeks

bevacizumab

Overall Number of Participants Analyzed 169 172
Measure Type: Number
Unit of Measure: study eyes
92 49
Time Frame Month 0 to 6
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aflibercept Bevacizumab
Hide Arm/Group Description

2.0 mg aflibercept every 4 weeks

aflibercept

1.25 mg bevacizumab every 4 weeks

bevacizumab

All-Cause Mortality
Aflibercept Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   1/180 (0.56%)      1/182 (0.55%)    
Show Serious Adverse Events Hide Serious Adverse Events
Aflibercept Bevacizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/180 (7.78%)      14/182 (7.69%)    
Blood and lymphatic system disorders     
Hypercoagulation  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Cardiac disorders     
Acute myocardial infarction  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Atrial fibrillation  1  0/180 (0.00%)  0 1/182 (0.55%)  2
Cardiac failure congestive  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Myocardial infarction  1  1/180 (0.56%)  1 1/182 (0.55%)  1
Ear and labyrinth disorders     
Vertigo  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Eye disorders     
Non-infectious endophthalmitis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Immune system disorders     
Hypersensitivity  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Infections and infestations     
Bronchitis  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Clostridium difficile colitis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Diabetic foot infection  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Escherichia infection  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Meningitis streptococcal  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Pneumonia  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Sepsis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Investigations     
Blood sodium decreased  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Metabolism and nutrition disorders     
Dehydration  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Hypoglycaemia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Osteoarthritis  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lymphoplasmacytoid lymphoma/immunocytoma  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Neoplasm malignant  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Oesophageal adenocarcinoma  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Renal cancer  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Waldenstrom's macroglobulinaemia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Nervous system disorders     
Cerebrovascular accident  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Cerebrovascular stenosis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Psychiatric disorders     
Alcohol abuse  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Mental status changes  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Chronic obstructive pulmonary disease  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Pulmonary embolism  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Surgical and medical procedures     
Hernia repair  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Vascular disorders     
Hypertension  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Hypertensive crisis  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Peripheral vascular disorder  1  1/180 (0.56%)  1 0/182 (0.00%)  0
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aflibercept Bevacizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   82/180 (45.56%)      98/182 (53.85%)    
Blood and lymphatic system disorders     
Anaemia  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Cardiac disorders     
Bradycardia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Cardiac failure congestive  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Myocardial infarction  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Vertigo positional  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Eye disorders     
Angle closure glaucoma  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Blepharitis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Cataract  1  4/180 (2.22%)  4 2/182 (1.10%)  3
Cataract nuclear  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Charles Bonnet syndrome  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Conjunctival haemorrhage  1  4/180 (2.22%)  4 14/182 (7.69%)  16
Conjunctival hyperaemia  1  1/180 (0.56%)  4 1/182 (0.55%)  1
Conjunctival oedema  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Diabetic retinopathy  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Dry eye  1  1/180 (0.56%)  2 2/182 (1.10%)  3
Eye irritation  1  3/180 (1.67%)  3 2/182 (1.10%)  3
Eye pain  1  6/180 (3.33%)  8 3/182 (1.65%)  3
Eye pruritus  1  1/180 (0.56%)  1 1/182 (0.55%)  1
Eye swelling  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Eyelid disorder  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Eyelid pain  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Foreign body sensation in eyes  1  1/180 (0.56%)  3 1/182 (0.55%)  1
Glaucoma  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Keratopathy  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Lacrimation increased  1  1/180 (0.56%)  1 1/182 (0.55%)  2
Macular hole  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Macular ischaemia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Macular oedema  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Maculopathy  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Metamorphopsia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Ocular discomfort  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Ocular hyperaemia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Ocular hypertension  1  1/180 (0.56%)  2 1/182 (0.55%)  1
Ophthalmoplegia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Optic disc hyperaemia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Papilloedema  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Photophobia  1  1/180 (0.56%)  1 1/182 (0.55%)  2
Photopsia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Posterior capsule opacification  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Retinal collateral vessels  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Retinal exudates  1  2/180 (1.11%)  2 3/182 (1.65%)  3
Retinal haemorrhage  1  0/180 (0.00%)  0 3/182 (1.65%)  3
Retinal vascular disorder  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Retinal vein occlusion  1  2/180 (1.11%)  2 2/182 (1.10%)  2
Subretinal fluid  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Vision blurred  1  1/180 (0.56%)  1 5/182 (2.75%)  8
Visual acuity reduced  1  3/180 (1.67%)  4 7/182 (3.85%)  7
Visual impairment  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Vitreous adhesions  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Vitreous detachment  1  6/180 (3.33%)  6 3/182 (1.65%)  3
Vitreous floaters  1  6/180 (3.33%)  6 8/182 (4.40%)  8
Vitreous opacities  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Gastrointestinal disorders     
Abdominal pain  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Constipation  1  1/180 (0.56%)  1 1/182 (0.55%)  1
Haematochezia  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Large intestine polyp  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Nausea  1  2/180 (1.11%)  2 1/182 (0.55%)  1
Stomatitis  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Vomiting  1  0/180 (0.00%)  0 1/182 (0.55%)  1
General disorders     
Asthenia  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Catheter site haemorrhage  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Chest pain  1  3/180 (1.67%)  3 0/182 (0.00%)  0
Cyst  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Facial pain  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Pyrexia  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Immune system disorders     
Drug hypersensitivity  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Hypersensitivity  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Sarcoidosis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Seasonal allergy  1  3/180 (1.67%)  3 0/182 (0.00%)  0
Infections and infestations     
Acarodermatitis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Atypical pneumonia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Bacterial infection  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Bronchitis  1  4/180 (2.22%)  4 2/182 (1.10%)  2
Bronchitis viral  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Cellulitis  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Clostridium difficile colitis  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Clostridium difficile infection  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Diverticulitis  1  1/180 (0.56%)  1 1/182 (0.55%)  1
Gastroenteritis viral  1  2/180 (1.11%)  2 0/182 (0.00%)  0
Gingivitis  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Haematoma infection  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Herpes zoster  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Influenza  1  1/180 (0.56%)  1 1/182 (0.55%)  1
Localised infection  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Nasopharyngitis  1  3/180 (1.67%)  3 6/182 (3.30%)  6
Pharyngitis streptococcal  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Pneumonia  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Respiratory tract congestion  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Respiratory tract infection  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Sinusitis  1  2/180 (1.11%)  2 5/182 (2.75%)  5
Tinea pedis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Tooth infection  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Upper respiratory tract infection  1  2/180 (1.11%)  2 2/182 (1.10%)  2
Urinary tract infection  1  3/180 (1.67%)  3 6/182 (3.30%)  6
Injury, poisoning and procedural complications     
Ankle fracture  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Arteriovenous fistula aneurysm  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Cataract traumatic  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Contusion  1  2/180 (1.11%)  2 0/182 (0.00%)  0
Corneal abrasion  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Fall  1  2/180 (1.11%)  2 5/182 (2.75%)  5
Joint injury  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Ligament sprain  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Periorbital haemorrhage  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Procedural pain  1  1/180 (0.56%)  1 1/182 (0.55%)  1
Tendon injury  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Tooth fracture  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Wound  1  1/180 (0.56%)  1 1/182 (0.55%)  1
Wrist fracture  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Investigations     
Blood cholesterol increased  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Blood glucose increased  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Blood pressure increased  1  1/180 (0.56%)  1 3/182 (1.65%)  3
Blood sodium decreased  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Intraocular pressure increased  1  1/180 (0.56%)  2 5/182 (2.75%)  5
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/180 (0.56%)  1 2/182 (1.10%)  2
Gout  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Hypertriglyceridaemia  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Hypoglycaemia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/180 (1.67%)  3 2/182 (1.10%)  2
Back pain  1  1/180 (0.56%)  1 3/182 (1.65%)  3
Costochondritis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Joint swelling  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Muscle spasms  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Muscular weakness  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Musculoskeletal stiffness  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Myalgia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Osteoarthritis  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Pain in extremity  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Plantar fasciitis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Rotator cuff syndrome  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Temporomandibular joint syndrome  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Bladder neoplasm  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Squamous cell carcinoma  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Nervous system disorders     
Carpal tunnel syndrome  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Cervical radiculopathy  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Dizziness  1  2/180 (1.11%)  2 2/182 (1.10%)  3
Headache  1  2/180 (1.11%)  2 6/182 (3.30%)  6
Metabolic encephalopathy  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Migraine  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Neuralgia  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Optic neuritis  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Parkinson's disease  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Polyneuropathy  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Sciatica  1  1/180 (0.56%)  1 1/182 (0.55%)  1
Syncope  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Tremor  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Psychiatric disorders     
Anxiety  1  1/180 (0.56%)  1 1/182 (0.55%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/180 (0.56%)  1 2/182 (1.10%)  2
Haematuria  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Urinary retention  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Prostatomegaly  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Vulva cyst  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Cough  1  3/180 (1.67%)  3 1/182 (0.55%)  1
Dyspnoea  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Oropharyngeal pain  1  1/180 (0.56%)  1 1/182 (0.55%)  1
Paranasal sinus discomfort  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Pulmonary hypertension  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Sleep apnoea syndrome  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Skin and subcutaneous tissue disorders     
Pruritus  1  0/180 (0.00%)  0 2/182 (1.10%)  2
Rash pruritic  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Urticaria  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Surgical and medical procedures     
Endodontic procedure  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Peripheral nerve decompression  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Tooth extraction  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Vascular disorders     
Aneurysm  1  0/180 (0.00%)  0 1/182 (0.55%)  1
Haematoma  1  1/180 (0.56%)  1 0/182 (0.00%)  0
Hypertension  1  3/180 (1.67%)  3 5/182 (2.75%)  5
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Trial results can not be discussed until they have been made available to the public.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principal Investigator of the SCORE2 Data Coordinating Center
Organization: The Emmes Corporation
Phone: 301-251-1161
EMail: score2@emmes.com
Other Publications:
Layout table for additonal information
Responsible Party: The Emmes Company, LLC
ClinicalTrials.gov Identifier: NCT01969708     History of Changes
Other Study ID Numbers: SCORE2
U10EY023529 ( U.S. NIH Grant/Contract )
U10EY023533 ( U.S. NIH Grant/Contract )
U10EY023521 ( U.S. NIH Grant/Contract )
First Submitted: October 22, 2013
First Posted: October 25, 2013
Results First Submitted: March 7, 2018
Results First Posted: August 21, 2018
Last Update Posted: May 8, 2019